C. Analysis, Balance and Distribution of Harms and Benefits

C1. Minimal Risk

The standard of minimal risk is commonly defined as follows: if potential subjects can reasonably be expected to
regard the probability and magnitude of possible harms implied by participation in the research to be no greater than
those encountered by the subject in those aspects of his or her everyday life that relate to the research then the
research can be regarded as within the range of minimal risk. Above the threshold of minimal risk, the research
warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective subjects.
There is a similar threshold regarding undue or excessive offers of benefit. As an offer of payment in relation to
research participation exceeds the normal range of benefits open to the research subject, it is increasingly likely to
amount to an undue incentive for participation (see Section 2B).

This concept of minimal risk raises special issues in clinical research, especially clinical trials, in which patients
suffering from disease participate in research on interventions undertaken for purposes of therapy. In such research,
the procedures to which the subject is exposed may be either directly required for the therapy that the patient is
undergoing for illness, or they may be undertaken because extra actions (for example, more X-rays, blood samples,
colonoscopies) are needed for proper analysis of the therapy. Hence, risks in clinical trials can be described as either
therapeutic or non-therapeutic.

In some areas of treatment (for example, surgery, chemotherapy or radiation therapy), the treatments themselves are
known to pose considerable risks of harm. Such therapeutic risks may be regarded as within the range of minimal
risks for patient-subjects, since they are inherent in the treatment that the patient will be undergoing as a part of his or
her current everyday life. Adherence to the principle of clinical equipoise1 (see Section 7) requires that the fundamental
ethical consideration in the decision to expose patients to experimental procedures derives from the premise that the
interventions being tested are not different in terms of the anticipated balance between their harms and benefits.
Hence, the idea that considerable anticipated therapeutic risks might also be within the range of minimal risks extends
to the therapies in the trial.

This consideration does not apply to non-therapeutic risks, which arise from actions that go beyond the needs of the
subject as a patient, and that are incurred only for the needs of the research. REBs should be sensitive to this
distinction for all research projects. They should recognize the need to minimize harms, and to ensure that these
harms are proportionate to the benefits that might be expected from the knowledge gained from the study. For projects
that involve both therapeutic and non-therapeutic risks, the risks that are required for therapy as opposed to research
need to delineated.

C2. Scholarly Review as Part of Ethics Review

Article 1.5

   a.The REB shall satisfy itself that the design of a research project that poses more than minimal risk is
     capable of addressing the questions being asked in the research.

   b.The extent of the review for scholarly standards that is required for biomedical research that does not
     involve more than minimal risk will vary according to the research being carried out.

   c.Research in the humanities and the social sciences which poses, at most, minimal risks shall not
     normally be required by the REB to be peer reviewed.

   d.Certain types of research, particularly in the social sciences and the humanities, may legitimately have
     a negative effect on public figures in politics, business, labour, the arts or other walks of life, or on
     organizations. Such research should not be blocked through the use of harms/benefits analysis or
     because of the potentially negative nature of the findings. The safeguard for those in the public arena
     is through public debate and discourse and, in extremis, through action in the courts for libel.

Traditions for scholarly and ethical review undertaken vary between disciplines. The following mechanisms are among
those that should be considered by the REB. The REB may:

     conclude that the proposed research has already passed appropriate peer review, for example by a funding
     agency;

     establish an ad hoc independent external peer review;

     establish a permanent peer review committee reporting directly to the REB;

     assume complete responsibility for the scholarly merit, which would require that it have the necessary scholarly
     expertise in the discipline to carry out peer review of the research in question.

REBs should normally avoid duplicating previous professional peer-review assessments unless there is a good and
defined reason to do so. However, they may request the researcher to provide them with the full documentation of
those reviews.

In evaluating the merit and the scholarly standards of a research proposal, the REB should be concerned with a global
assessment of the degree to which the research might further the understanding of a phenomenon, and not be driven
by factors such as personal biases or preferences. REBs should not reject research proposals because they are
controversial, challenge mainstream thought, or offend powerful or vocal interest groups. The primary tests to be used
by REBs should be ethical probity and high scientific and scholarly standards.

Article 1.5(d) reflects the tradition in the humanities and the social sciences for researchers to publish their results and
then debate with their readers and reviewers the merits of what they have written. In the context of harms and benefits
to research subjects, prior to starting the research the risks of censorship of ideas through peer review do not seem
justified. Nothing in this section, however, shall be interpreted to mean that other relevant parts of this Policy, such as
the need for REB review, interview protocols, free and informed consent and privacy are not applicable to their
research.